Neisseria gonorrhoeae
Clinical Specimen Submission Guidance
Submit all specimens to 50 Orms St, Providence RI 02904. Open Monday to Friday 8:30 AM to 4:30 PM
STI & Arbovirus Laboratory 401-222-5591
Neisseria gonorrhoeae
Gonoccal Infection (Gonoccal infection)
Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (NG) testing is performed using the FDA-cleared Aptima Combo 2 Assay for CT/NG (Hologic) on the Panther System.
FDA cleared specimens include: male and female urine specimens, Clinician-collected swabs (endocervical, vaginal, male urethral, pharyngeal, rectal) and patient-collected vaginal swabs.
Results should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine an overall clinical diagnosis.
Specimen Collection: (Follow instructions for collection printed on each collection kit) This test is only approved for specimen types listed in Specimen Section. Specimens received from other sites will be rejected.
NOTE: The performance of the Aptima Combo 2 Assay has not been evaluated in adolescents less than 14 years of age.
NOTE: SPECIMENS RECEIVED FROM ADOLESCENTS LESS THAN 14 YEARS OF AGE WILL NOT BE TESTED BY RISHL.
Aptima Unisex Swab Collection Kit: (Clinician- collected) endocervical and male urethral.
Aptima Multitest Swab Collection Kit: (Clinician or patient collected) vaginal, pharyngeal, and rectal.
Refrigerate specimens at 2-8⁰C.
Note: if requested, a single Clinician-collected Unisex Swab Collection Kit (endocervical) or Clinician-collected Multitest Swab Collection Kit (vaginal) can be used for testing Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.
Aptima Urine Collection Kit: male and female urine specimens.
Note: if requested, a single Urine Collection Kit can be used for testing Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.
For additional information refer to the specimen collection tube guidance chart
CLIA regulations require specimens be labeled with at least two patient identifiers. Examples of identifiers are first and last name, date of birth, chart/medical record number. The specimen container must be labeled to match the test requisition or the electronic order.
Rhode Island State Health Laboratories (RISHL) test requisition form https://health.ri.gov/forms/LabRequisitionForm.pdf
Chlamydia / Gonorrhea
Indicate source type in Source/Site box on requisition
Refrigerate prior to transport at 2-8⁰C.
Swab specimen must be received within 60 days of collection.
Urine specimen must be received with in 30 days of collection.
Refrigerated: Transport and deliver to the laboratory within 24 hours of collection at 2-8°C in a cooler able to maintain specimen temperature. A plug-in electric cooler is recommended, however, a cooler packed with excess frozen gel packs is acceptable as long as the transport temperature is maintained at 2-8°C.
Specimens must be packaged & transported in accordance with current federal shipping regulations.
Specimens not received in approved collection kit will be rejected.
If specimens are received outside of the required transport temperature range, they will not be tested, and a rejection report will be issued.
The following rejection criteria will be used to ensure accurate specimen information and specimen condition for testing:
- Specimen received outside acceptable transport range
- Demographics different of specimen
- Two identifiers required on specimen / Unable to read identifiers on specimen
- Expired/ incorrect collection kit
- Insufficient quantity
- Urine cup received
- No specimen received
- Specimen leaked in transit
- Test not evaluated in adolescents < 14
- No swab received
- Specimen too old
Negative
Providers must report patient information on Gonoccal Infection within 4 days using the RIDOH reportable disease form.
3 Business Days
Kits are available from the RISHL Center for Laboratory Support Services and may be obtained Monday-Friday between 8:30 am and 4:30 pm. Kit order forms can be emailed to ridoh.centralservices@health.ri.gov